Speakers from Authorities and Public Health Organisations: Dara Corrigan Invitation to the U.S. Food & Drug Administration (FDA) Dr Rainer Gnibl District Government of Upper Bavaria Mag.pharm. Andreas Kraßnigg Austrian Agency for Health and Food Safety (AGES) Kevin O’Donnell Irish Health Products Regulatory Authority (HPRA) (form. IMB) Edit Szőcs Hungarian Drug Inspectorate, National Institute of Pharmacy (NIP) Maria Wängelin Swedish Medical Products Agency (MPA) Speakers from the Industry: Qualified Person Forum 2014 Vienna, Austria 27 – 28 November 2014 Justin Barry Midatech Biogune Richard M. Bonner, Qualified Person, Chairman of the Qualified Person Association, form. with Eli Lilly Dr Christopher Burgess EQPA, form. with Glaxo Dr Dagmar Chase European CRO Federation Dr Susanne Ding Boehringer Ingelheim Dr Oskar Enzersberger Baxter Dr Afshin Hosseiny Tabriz Consulting Dr Ulrich Kissel Roche Pharma Sue Mann Sue Mann Consultancy Ann McGee McGee Pharma International, form. Senior Inspector of the Irish Medicines Board Geneviève Meeus Johnson & Johnson Dr Gabriele Oleschko Merck KGaA Frank Raisch GSK Dr Rolf Ratke AbbVie Stefan Reintgen Team Connex Dr Bernd Renger Immediate Past Chairman of the EQPA Gillian Renouf InterMune Niina Taylor Pfizer Philippe Van de Hofstadt B&C Group With three Pre-Conference Sessions on 26 November 2014: Investigational Medicinal Products Risk Management in the Supply Chain OOS and OOT: What’s important for QPs Welcome Dear Colleagues, The European QP Association Forum has been becoming a major event for European Qualified Persons. Speakers from EMA and various national authorities as well as QPs have been sharing their view of roles and responsibilities of the Qualified Person. Hoping to continue the success of the QP Forum, the Advisory Board of the QP Association has set up the programme at hand for the 2014 Forum to give you an update about recent developments and important matters to consider. Representatives from the authorities as well as QPs and well-known experts will present latest issues and share their point of view. During the three pre-conference sessions and the six parallel sessions at the Forum, various case studies will be presented and discussed to come up with possible solutions. Make use of this event by exchanging experiences with your colleagues and by establishing informal contact and networking. I would like to invite you to this unique opportunity, and I look forward to meeting you. Best regards, Richard M. Bonner Chairman of the Qualified Person Association Background Over the past few years the role and duties of the Qualified Person keep increasing in significance and scope. Being the key person in the quality function of a pharmaceutical company, the QP has to consider many issues to fulfil the responsibilities and to comply with the European legislation. Objective This Conference is designed by QPs for QPs as an International Expert Forum with focus on sharing information and experience and on discussing the critical areas of the QP’s daily work. Target Group The Forum is designed for all Qualified Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons. Forum Moderator Dr Christopher Burgess Important Information! The presentations of the QP Forum and the Pre-Conference Workshop/ Session will be available for download and your print-out 1 week before the conference. You will also receive a USB memo stick when you register in Lisbon. Note: there will be no print-outs available during the conference. Pre-Conference Sessions Programme QP Forum 26 November 2014 27 – 28 November 2014 Full Day Pre-Conference Session Specific Requirements for IMPs Facilitated by: IMP Working Group yy yy yy yy New legislation impacting IMP QPs GMP in different clinical phases The Product Specification File - PSF Interactive case studies – decision making of IMP QPs 1/2 Day Pre-Conference Session Risk Management in the Supply Chain Facilitated by: Richard M. Bonner / Afshin Hosseiny / Edit Szőcs yy What the QP needs to know about Supply Chain Risk Management yy What inspectors expect from the QP 1/2 Day Pre-Conference Session OOS and OOT: What’s important for QPs Facilitated by: Christopher Burgess / Bernd Renger yy How the QP can rely on the Quality System yy How to handle IPC results impacting the product’s final quality The QP in a Global Environment: a positive Picture; Reflections about Perceptions yy Perceptions and self-understanding yy Roles of QPs in a global environment ÂÂ Rolf Ratke Current and future Activities of the FDA yy EU Mutual Reliance Drug Quality Initiative yy Pharmaceutical Quality for the 21st Century yy Lifecycle Quality Risk Management ÂÂ Dara Corrigan The Role of the QP in Product Recalls yy EU-GMP Chapter 8 yy Critical Defects and Risk Management yy Rapid Alert and communication between National Authorities and the QP ÂÂ Edit Szőcs What the QP needs to know about Quality by Design yy Know your process yy Risk Management yy Exceptional Release ÂÂ Oskar Enzersberger Law and Order yy Liability yy Indemnification yy Insurance ÂÂ Frank Raisch What the QP needs to know about Excipient Quality yy Transparency and the control of the supply chain yy Key criteria input yy Definition of standards ÂÂ Gabriele Oleschko The Written Confirmation and the QP: What Inspectors expect yy Role and responsibilities of the QP yy Interface with supplier qualification and the Quality System ÂÂ Rainer Gnibl Parallel Sessions Social Event Working on Case Studies 1) Update on GMP-relevant topics and what QPs are expected to do yy Discussion, questions, answers ÂÂ Bernd Renger and Rainer Gnibl 2) Annex 16 – how to live with it yy Discussion, questions, answers ÂÂ Ulrich Kissel and Andreas Kraßnigg 3) QP Scenarios: Would you know what to do? yy Make decisions based on real-life situations ÂÂ Sue Mann and Gillian Renouf On 27 November, you are cordially invited to a social event in Vienna. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere. Special Offer with Lufthansa – Discounted Travel 4) The Role of the QP in an R&D Environment yy Challenges with NCEs & Biotech bulk drug substances yy Comparator sourcing and handling ÂÂ IMP Working Group 5) How to interpret the PQR yy What the QP can and should get out of it ÂÂ Ann McGee and Kevin O’Donnell 6) How to deal with Time Pressure yy Key tools to plan, organise and set priorities to get the right things done, every day. ÂÂ Afshin Hosseiny and Stefan Reintgen You will be able to attend three of these parallel sessions. Please choose the ones you like to attend when you register for the Forum. As an ECA course or conference attendee, you will receive up to 20% discounted travel fares (according to availability). And as Lufthansa German Airlines offers a comprehensive global route network linking major cities around the world you will most likely be able to benefit from these special prices and conditions. And this is how it works: Once you registered for a course or conference you will receive a link together with your registration confirmation. Opening that link will take you to the Mobility Partner Program web-site where you can enter a code in the “Access to Event Booking” area you will also receive. This will take you into an online booking platform that will automatically calculate the discount offered or provide you with an even better offer if another promotional fare is available. Q&A Session During the 2 days of the Forum a bulletin board will be set up where delegates can post their question cards. The answers will be given by the expert speakers in this dedicated session and published in the members’ area of the EQPA web-site. Qualified Person Forum 2014 • Vienna, Austria • 27 – 28 November 2014 Speakers Speakers from Authorities and Public Health Organisations: Dara Corrigan, FDA, USA Assistant Commissioner for Global Regulatory Policy. Dr Oskar Enzersberger, Baxter AG, Austria Qualified Person. Dr Rainer Gnibl, District Government of Upper Bavaria, Germany GMP Inspector for the District Government and the EMA. Dr Afshin Hosseiny, Tabriz Consulting, U.K. Qualified Person and Managing Director. Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES), Austria Head Pharmaceutical Inspections and Member of Annex 16 Drafting Group. Dr Ulrich Kissel, Roche Pharma AG, Germany Qualified Person and Advisory Board member of the Qualified Person Association. Kevin O’Donnell, PhD, Irish Health Products Regulatory Authority (HPRA) (form. IMB), Ireland Market Compliance Manager. Edit Szőcs, Hungarian Drug Inspectorate, National Institute of Pharmacy (NIP), Hungary Inspector at the Hungarian Drug Inspectorate, National Institute of Pharmacy (NIP), Advisory Board member of the Qualified Person Association. Maria Wängelin, Medical Products Agency (MPA), Sweden GDP/GMP Inspector. Speakers from the Industry: Justin Barry, Midatech Biogune, Spain Managing Director. Richard M. Bonner, Chairman of the EQPA Qualified Person, Chairman of the Qualified Person Association, formerly with Eli Lilly. Dr Christopher Burgess, formerly with Glaxo, U.K. Qualified Person, Advisory Board member of the Qualified Person Association. Visiting Professor at the Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS). Dr Dagmar Chase, European CRO Federation (EUCROF) Vice President EUCROF and Managing Director of Clinrex GmbH. Dr Susanne Ding, Boehringer Ingelheim, Germany Qualified Person for Investigational Medicinal Products. Sue Mann, Sue Mann Consultancy Ltd. U.K. Qualified Person and QP Assessor working on behalf of the MHRA, representing the Royal Pharmaceutical Society. Ann McGee, McGee Pharma International, Ireland Managing Director and Principal Consultant. Former Senior Inspector of the Irish Medicines Board and Deputy Chair of PIC/S. Geneviève Meeus, Janssen Pharmaceutica NV (part of Johnson & Johnson), Belgium Director QA Clinical Supply Chain/ IMP QP. Dr Gabriele Oleschko, Merck KGaA, Germany Qualified Person and Senior Manager Quality Operations. Frank Raisch, GSK, Germany Legal Counsel and Attorney-at-Law. Dr Rolf Ratke, AbbVie Biotechnology, Germany Qualified Person and Director Biologics Quality Assurance. Stefan Reintgen, Team Connex, Germany Trainer and Coach, formally working for BASF and Celanese Dr Bernd Renger, EQPA Immediate Past Chairman of the Qualified Person Association. Gillian Renouf, InterMune, U.K. and Ireland Qualified Person and Senior Director Quality. Niina Taylor, Pfizer, U.K. Qualified Person and Director Quality Assurance. Philippe Van de Hofstadt, B&C Group, Belgium CEO of B&C, a Clinical Research Packaging & Logistics Organisation. Date Full Day Pre-Conference Session: Specific Requirements for IMPs Wednesday, 26 November 2014, 9.30 – 18.00 (Registration and coffee: 9.00 – 9.30) Date ½ Day Pre-Conference Session: Risk Management in the Supply Chain Wednesday, 26 November 2014, 13.00 – 18.00 (Registration, snacks and coffee: 12.30 – 13.00) Date ½ Day Pre-Conference Session: OOS and OOT: what’s important for QPs Wednesday, 26 November 2014, 13.30 – 18.00 (Registration, snacks and coffee: 13.00 – 13.30 Welcome Reception for all participants Wednesday, 26 November 2014, 18.00 – 19.00 Date QP Forum Thursday, 27 November 2014, 9.00 – 18.00 (Registration: Wednesday, 26 November 18.00 – 19.00 and Thursday 27 November 2014, 8.00 – 9.00) Friday, 28 November 2014, 8.30 – 14.30 Venue Austria Trend Hotel Park Royal Palace Vienna Schlossallee 8 1140 Vienna Austria Tel.: +43 1 8911 0 Fax:+43 1 8911 9050 Fees for QP Forum QP Association Members € 1.590,- per delegate plus VAT. EU GMP Inspectorates € 895,- per delegate plus VAT. Non-QP Association Members € 1.790,- per delegate plus VAT. The conference fee is payable in advance after receipt of invoice and includes electronic conference documentation, welcome reception, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable. Fees for Full Day Pre-Conference Session: Specific Requirements for IMPs € 890,- per delegate plus VAT. The fee is payable in advance after receipt of invoice and includes electronic conference documentation, welcome reception, lunch and all refreshments. VAT is reclaimable. Fees for ½ Day Pre-Conference Session: Risk Management in the Supply Chain € 590,- per delegate plus VAT. The fee is payable in advance after receipt of invoice and includes electronic conference documentation, welcome reception and all refreshments. VAT is reclaimable. Fees for ½ Day Pre-Conference Session: OOS and OOT: What’s important for QPs € 590,- per delegate plus VAT. The fee is payable in advance after receipt of invoice and includes electronic conference documentation, welcome reception and all refreshments. VAT is reclaimable. Saving opportunities: Book both the QP Forum and a Pre-Conference Session: Delegates who attend the QP Forum and a Pre-Conference Session will get a discount of 200€ on the QP Forum. Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation link when you have registered for the event. Please use this link for your room reservation or be sure to mention QP Association to receive the specially negotiated rate (single room 125,- Euros per night incl. breakfast) for the duration of your stay. Reservation should be made directly with the hotel not later than 5 October 2014. Early reservation is recommended. Registration Via the attached reservation form, by e-mail to [email protected] or by fax to +49 6221 / 84 44 34 . Or you register online at www.qp-forum.org. Conference Language The official conference language will be English. Organisation / Contact CONCEPT HEIDELBERG P.O. Box 10 17 64 D-69007 Heidelberg, Germany Phone +49 (0) 62 21/84 44-0, Fax +49 (0) 62 21/84 44 34 E-mail: [email protected] www.concept-heidelberg.de For questions regarding content: Mr Wolfgang Schmitt (Operations Director) at +49-62 21 / 84 44 39, or per e-mail at [email protected]. For questions regarding reservation, hotel, organisation etc: Ms Marion Grimm (Organisation Manager) at +49 (0) 62 21 / 84 44 18, or per e-mail at [email protected]. Country Important: This is a binding registration and above fees are due in case of cancellation or non-appearance. If you cannot take part, you have to inform us in writing. The cancellation fee will then be calculated according to the point of time at which we receive your message. In case you do not appear at the event without having informed us, you will have to pay the full registration fee even if you have not made the payment yet. You are not entitled to participate in the conference until we have received your payment (receipt of payment will not be confirmed)! E-mail ( Please fill in) Phone / Fax City Street / P.O. Box P.O Number (if applicable) Zip Code Important: Please indicate your company’s VAT ID Number D-69007 Heidelberg CompanyDepartment CONCEPT HEIDELBERG Postfach 10 17 64 Fax 06221/84 44 34 Title, first name, surname Terms of payment: Payable without deductions within 10 days after receipt of invoice. About the European QP Association The European Qualified Person (QP) Association was founded on 7 July 2006 by the European Compliance Academy’s (ECA) Advisory Board Members. With this unique association the ECA wants to provide QPs in Europe with a platform allowing them to exchange their experience, discuss the latest regulatory requirements, to identify and address difficulties and challenges and to support a harmonised European approach. * Ms * Mr * Optional Pre-Conference Session, Vienna, Austria, 26 November 2014 Please choose one of the following: * Full Day Session “Investigational Medicinal Products” * 1/2 Day Session “Risk Management in the Supply Chain” * 1/2 Day Session “OOS and OOT: What’s important for QPs ” * Qualified Person Forum 2014, Vienna, Austria, 27-28 November 2014 Please choose three of the six parallel sessions: * Session 1: Update on GMP-relevant topics and what QPs are expected to do * Session 2: Annex 16 – how to live with it * Session 3: QP Scenarios: Would you know what to do? * Session 4: The Role of the QP in an R&D Environment * Session 5: How to interpret the PQR * Session 6: How to deal with Time Pressure Reservation Form (Please complete in full) If the bill-to-address deviates from the specification to the right, please fill out here: General Terms of Business If you cannot attend the conference you have two options: 1. We are happy to welcome a substitute colleague at any time. 2. If you have to cancel entirely, we must charge the following processing fees: Cancellation • until 2 weeks prior to the conference 10 % of the registration fee. • until 1 week prior to the conference 50 % of the registration fee. • within 1 week prior to the conference 100 % of the registration fee. CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without notice or to cancel an event. If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. CONCEPT HEIDELBERG will not be responsible for discount airfare penalties or other costs incurred due to a cancellation. More information about the QP Association and a membership application form are available at www. qp-association.eu. About CONCEPT HEIDELBERG Founded in 1978, CONCEPT HEIDELBERG is the leading organiser of seminars on pharmaceutical production, quality control, quality assurance and GMP in Europe. This year more than 240 events will be organised by CONCEPT HEIDELBERG. The European QP Association has entrusted CONCEPT HEIDELBERG with the organisation of its events. #
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